What are the dosing guidelines for clonidine (Clonidine) Extended Release (ER) in children?

Dosing Guidelines for Clonidine Extended Release (ER) in Children

The recommended dosing for clonidine extended release (ER) in children aged 6-17 years is to start at 0.1 mg once daily and gradually titrate by 0.1 mg increments weekly until desired response is achieved, with most therapeutic doses ranging from 0.2-0.6 mg/day and not exceeding 0.4 mg/day for ADHD treatment. 1

Age Restrictions and Initial Dosing

• Clonidine ER is FDA-approved for children and adolescents aged 6-17 years 2
• Not recommended for children under 6 years of age 1
• Initial dosing recommendations:
  • Start with 0.1 mg once daily at bedtime 1
  • For ADHD treatment: Begin with 0.1 mg at bedtime and titrate gradually 2

Titration Schedule

• Increase dose by 0.1 mg increments weekly 1
• Allow sufficient time between dose adjustments to assess clinical response and tolerability
• Most patients respond to doses between 0.2-0.6 mg/day 1
• Maximum recommended daily dose:
  • For ADHD: 0.4 mg/day 2
  • For hypertension in children ≥12 years: up to 2.4 mg/day (though rarely needed) 1

Weight-Based Considerations

For optimal dosing based on physiologically based pharmacokinetic modeling:

• Children 6-17 years: 0.9 mg/day orally 3
• For specific conditions like neonatal abstinence syndrome: 30 μg/kg orally for neonates 3

Administration Guidelines

• Administer at consistent times each day
• May be taken with or without food
• Extended-release formulation should be swallowed whole, not crushed or chewed
• Evening/bedtime administration may be preferred to minimize daytime sedation

Monitoring Requirements

• Blood pressure and heart rate monitoring, especially during initiation and dose adjustments 1
• Monitor for signs of:
  • Orthostatic hypotension
  • Excessive sedation
  • Bradycardia
  • CNS effects (dizziness, drowsiness)

Safety Considerations

• Never abruptly discontinue clonidine - must be tapered gradually to avoid rebound hypertension/hypertensive crisis 1
• Tapering schedule: Reduce dose by 0.1 mg every 3-7 days until discontinued
• Avoid in children with depression 1
• Use with caution in patients with:
  • Cardiovascular disease
  • Renal impairment
  • History of syncope or hypotension

Common Side Effects

• Sedation (most common)
• Dry mouth
• Drowsiness
• Fatigue
• Dizziness
• Constipation
• Bradycardia

Toxicity Considerations

• Doses exceeding 0.1 mg in children ≤4 years require direct medical evaluation 4
• Doses exceeding 0.2 mg in children 5-8 years require direct medical evaluation 4
• Doses exceeding 0.4 mg in children >8 years require direct medical evaluation 4
• Symptoms of toxicity typically appear within 4 hours of ingestion 4
• Severe toxicity (respiratory depression, coma) has been reported with doses ≥0.3 mg (0.015 mg/kg) 4

Alternative Considerations

• Guanfacine ER may be considered as an alternative with:
  • Higher specificity for alpha-2A receptors
  • Less pronounced sedation
  • Better side effect profile 1
• In some Asian countries like India, clonidine is dosed at 0.2-0.4 mg/day according to weight 5

Remember that clonidine ER has significant CNS effects and cardiovascular effects that require careful monitoring, especially during initiation and dose adjustments. The extended-release formulation helps minimize peak-related side effects compared to immediate-release formulations.